Specialty Generics Market Forecasts to 2028 – Global Analysis By Type (Oral Drugs, Injectables, Topical, Parenteral and Other Types), By Application (Hepatitis C, Multiple Sclerosis, Inflammatory Conditions, Oncology, Cardiovascular, Infectious Diseases, Autoimmune Diseases and Other Applications), By End User and By Geography
According to Stratistics MRC, the Global Specialty Generics Market is accounted for $69.9 billion in 2022 and is expected to reach $176.6 billion by 2028 growing at a CAGR of 16.7% during the forecast period. Once a specialty drug's patent expires, generic versions of it are referred to as specialty generics. Complex, chronic diseases like cancer, multiple sclerosis, and rheumatoid arthritis may all be treated with these medications. Specialty generics are less expensive than branded equivalents because they have lower development and marketing expenses.
According to the World Health Organization (WHO), the geriatric population increased from 1 billion in 2020 to 1.4 billion in 2021. By 2030, one in six people in the world will be aged 60 years and above.
Market DynamicsDriverIncreasing cases of chronic diseases to fuel the demand for specialty generics
Globally, there have been more incidences of numerous life-threatening illnesses, such as cancer, multiple sclerosis (MS), and HIV, and it is projected that this will lead to a rise in the use of specialty medications. For instance, according to data from the Global RA Network published in 2021, there are already 350 million individuals living with arthritis worldwide, and this number is likely to rise over the next few years. Additionally, according to data released by Globocan in 2020, 9.7% of the world's population, or Europe, represented 19.6% of cancer deaths and 22.8% of all cancer diagnoses.
RestraintHigh capital cost and complex manufacturing requirements
Due to the sophisticated manufacturing needs, greater capital expenditures, and generally lower quantities as a result of a smaller patient population, specialist generics have a more competitive market than regular generics. Specialty generic drugs typically require prior authorization to be ordered, specific handling, administration, and monitoring. These elements are further hindering the market growth.
OpportunityPatent expiration of specialty drugs
As payers and patients seek methods to save healthcare costs, demand for specialty generics is expanding globally. To ensure that patients who require advanced generic medicines have access to them, a number of well-known market participants are concentrating on the release of generic versions of medications. For instance, Teva Pharmaceuticals, Inc. introduced Revlimid (capsules containing lenalidomide) in the United States in March 2022. In order to treat multiple myeloma in adults, the first generic version of Revlimid was introduced in strengths of 5mg, 10mg, 15mg, and 25mg.
ThreatLack of awareness and low profitability
High complexity of specialist generic medicines, low profitability, and brand recognition and loyalty are important issues that, to some extent, restrict market expansion. People are bearing the burden of rising healthcare costs as a result of the general public's lack of knowledge about the availability of generic medications at pharmacies, which forces them to spend more on branded medications. During the projected period, these factors are anticipated to limit the market's growth.
Covid-19 ImpactThe COVID-19 pandemic's impact on the market caused the industry to grow more slowly as a result of the suspension of various research trials and studies following the big virus epidemic, lockdown limitations in industrial facilities, and a lack of qualified employees. Additionally, a number of pharmaceutical firms witnessed a reduction in their net revenues in 2020 as a result of COVID-19. Instead, due to widespread vaccinations, a relaxation of lockdown restrictions, and a rise in the need for specialist medications to treat chronic ailments, the market recovered in 2021 as compared to 2020.
The oral drugs segment is expected to be the largest during the forecast period
Oral Drugs segment is expected to have dominant share throughout the projection period. The quickest, simplest, and safest method of administration for generic medications is oral. As a result of their ease of use for frequent and sustained usage, self-administration, and lack of pain, they are the most often used and manufactured form of pharmaceuticals. The product launches credited with the segment's supremacy in the market attract the attention of market participants. For instance, Par Pharmaceutical, Inc. (Par), a subsidiary of Endo International plc, was granted FDA approval in January 2022 to market the country's first generic version of Merz's CUVPOSA (glycopyrrolate).
The oncology segment is expected to have the highest CAGR during the forecast period
Oncology segment accounted for lucrative growth over the forecasted period, because there are more generic cancer medications available and there is a greater demand for cancer treatment solutions that are effective. For instance, Sun Pharmaceutical Industries Ltd. introduced the generic version of Palbociclib, a breast cancer treatment from Pfizer, in India in January 2023. These factors are anticipated to boost segment growth due to the adoption of a Western lifestyle, excessive alcohol and tobacco use, poor dietary choices, and physical inactivity.
Region with largest shareNorth America is expected to have the largest share during the domination period, due to the existence of regulatory policies that favor the approval of innovative products. The American FDA has launched a number of initiatives aimed at streamlining the entire approval procedure. Thus, the Hatch-Waxman Act's Generic Drug User Free Amendments (GDUFA) were introduced by the U.S. FDA to accelerate the distribution of affordable, safe, and effective generic medications to the general population. Therefore, the major producers continually work to commercialize specialty generic medicines on the market.
Region with highest CAGRAsia Pacific region is anticipated to witness rapid growth throughout the extrapolated period, due to the expansion of biopharmaceutical companies in China and India, which is anticipated to drive the market in this region. Additionally, the region is expanding as a result of the favorable regulatory regulations governing the approval and introduction of new generic drugs there. However, pharmaceutical companies are continually working to promote specialty medications in the region. The market in the Asia-Pacific area has grown as a result of these factors.
Key players in the marketSome of the key players in Specialty Generics market include Akorn, Inc., Amneal Pharmaceuticals LLC, Bausch Health Companies Inc, Dr. Reddy’s Laboratories, Ltd., Endo International plc., Endo Pharmaceuticals Inc., Hikma Pharmaceuticals PLC, Lupin, Mallinckrodt, Mylan N.V., Novartis AG, Pfizer, Inc., Sandoz International GmbH, Sun Pharmaceutical Industries, Ltd., Teva Pharmaceuticals USA, Inc. and Viatris Inc..
Key DevelopmentsIn June 2022, Amneal Pharmaceuticals Inc., launched LYVISPAH (baclofen) a specialty product approved by U.S. FDA for the indication of multiple sclerosis and other spinal cord disorders.
In March 2022, Viatris Inc. announced receipt of the first FDA approval for a generic version of Symbicort Inhalation Aerosol, Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), in partnership with Kindeva Drug Delivery L.P. for the treatment of chronic obstructive pulmonary disease (COPD).
In January 2022, Lupin Limited partnered with the Chinese Shenzhen Foncoo Pharmaceutical Co., Ltd. The partnership aimed to sell complex generics and specialty medicines to China.
Types Covered
• Oral Drugs
• Injectables
• Topical
• Parenteral
• Other Types
Applications Covered
• Hepatitis C
• Multiple Sclerosis
• Inflammatory Conditions
• Oncology
• Cardiovascular
• Infectious Diseases
• Autoimmune Diseases
• Other Applications
End Users Covered
• Hospital Pharmacy
• Retail Pharmacy
• Specialty Pharmacy
• Online Pharmacies
• Other End Users
Regions Covered
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa
What our report offers- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (
Drivers, Constraints, Opportunities,
Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements